Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair.

BACKGROUND: Chronic postoperative pain is a major drawback of inguinal hernia repair. This study compared the frequency of chronic pain after laparoscopic (totally extraperitoneal patch, TEP) and open (Lichtenstein) repairs. METHODS: A randomized multicentre study with 5 years' follow-up was conducted on men with a primary inguinal hernia. Chronic pain was categorized as mild, moderate or severe by blinded observers. A subgroup analysis was performed on 121 patients who experienced moderate or severe pain at any time during follow-up. RESULTS: Overall, 1370 of 1512 randomized patients underwent surgery, 665 in the TEP and 705 in the Lichtenstein group. The total incidence of chronic pain was 11.0 versus 21.7 per cent at 1 year, 11.0 versus 24.8 per cent at 2 years, 9.9 versus 20.2 per cent at 3 years and 9.4 versus 18.8 per cent at 5 years in the TEP and Lichtenstein groups respectively (P < 0.001). After 5 years, 1.9 per cent of patients in the TEP and 3.5 per cent in the Lichtenstein group reported moderate or severe pain (P = 0.092). Of the 121 patients, 72 (59.5 per cent) no longer reported pain a median of 9.4 (range 6.7-10.8) years after operation. CONCLUSION: Five years after surgery only a small proportion of patients still report moderate to severe chronic pain. Laparoscopic inguinal hernia repair leads to less chronic pain than open repair. REGISTRATION NUMBER: NCT00568269 (http://www.clinicaltrials.gov).

Long-term cost-minimization analysis comparing laparoscopic with open (Lichtenstein) inguinal hernia repair.

BACKGROUND: Laparoscopic surgery has emerged as a new treatment modality for inguinal hernia repair. The aim of the present study was to analyse its long-term costs in relation to those of open repair. METHODS: A randomized multicentre study comparing totally extraperitoneal laparoscopic repair (TEP) with open repair by the Lichtenstein procedure was performed on men with a primary inguinal hernia. Long-term data on recurrences and complications up to 5 years after operation were collected. Taking treatment costs into consideration, a cost-minimization analysis was conducted. RESULTS: A total of 1370 patients had an inguinal hernia repair, 665 in the TEP and 705 in the Lichtenstein group. The total hospital cost for the index operation was 710.6 euro higher for TEP repair (P < 0.001). Including costs associated with recurrences and complications, this difference increased to 795.1 euro (P < 0.001). Taking community costs into account, the difference decreased by 503.1 euro to 292.0 euro (P = 0.024). CONCLUSION: This cost-minimization analysis, including complications, reoperations and community costs during follow-up of 5 years, showed that laparoscopic inguinal hernia repair had a small but significant increase in overall costs compared with open repair.

Discomfort five years after laparoscopic and Shouldice inguinal hernia repair: a randomised trial with 867 patients. A report from the SMIL study group.

BACKGROUND: In recent years long-term discomfort after inguinal hernia surgery has become an issue of great concern to hernia surgeons. Long-term results on discomfort from large randomised studies are sparse. METHODS: One-thousand one-hundred and eighty-three patients were randomised in a multicentre trial with the primary aim of comparing recurrence rates after laparoscopic TAPP and Shouldice repair. Evaluating late discomfort and its possible risk factors were secondary objectives, and are reported here. The patients were clinically examined after 1 and 5 years, and answered questionnaires 2 and 3 years postoperation. RESULTS: Of 1,068 operated patients, 867 were eligible for analysis after 5 years (81.2%). The percentage of patients experiencing discomfort of any kind were 8.5% in the TAPP group and 11.4% (p = 0.156) in the Shouldice group. Although discomfort was usually mild it was severe for 0.2 and 0.7%, respectively. Severe pain the first postoperative week was a risk factor for late discomfort in the Shouldice group (OR 2.25, P = 0.022) but not in the TAPP group. No other risk factor for late discomfort was found. CONCLUSION: There was no difference between late discomfort at five-year follow-up after laparoscopic TAPP and Shouldice repair. Discomfort was mostly mild and pain during the first postoperative week was a prognostic variable for late discomfort in Shouldice patients.

Recurrent inguinal hernia: randomized multicenter trial comparing laparoscopic and Lichtenstein repair.

BACKGROUND: The optimal treatment for recurrent inguinal hernia is of concern due to the high frequency of recurrence. METHODS: This randomized multicenter study compared the short- and long-term results for recurrent inguinal hernia repair by either the laparoscopic transabdominal preperitoneal patch (TAPP) procedure or the Lichtenstein technique. RESULTS: A total of 147 patients underwent surgery (73 TAPP and 74 Lichtenstein). The operating time was 65 min (range, 23-165 min) for the TAPP group and 64 min (range, 25-135 min) for the Lichtenstein group. Patients who underwent TAPP reported significantly less postoperative pain and shorter sick leave (8 vs 16 days). The recurrence rate 5 years after surgery was 19% for the TAPP group and 18% for the Lichtenstein group. CONCLUSION: The short-term advantage for patients who undergo the laparoscopic technique is less postoperative pain and shorter sick leave. In the long term, no differences were observed in the chronic pain or recurrence rate.

Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair.

BACKGROUND: Laparoscopic herniorrhaphy has emerged as a recognized operative method for inguinal hernia repair. This study compared the short-term results of two tension-free methods of repair: totally extraperitoneal (TEP) laparoscopic patch repair and the open Lichtenstein mesh technique. METHODS: A total of 1513 men from 11 hospitals who presented with a primary unilateral inguinal hernia were randomized to one of the two methods. Operating time, short-term complications, reoperations, postoperative pain, consumption of analgesics, sick leave and time to resumption of normal physical activities were recorded. RESULTS: Some 1371 of the 1513 men underwent surgery, 665 in the TEP group and 706 in the Lichtenstein group. The median duration of operation was 55 min for both procedures and 91.0 percent of the patients in both groups were discharged on the day of operation. Patients in the TEP group experienced less postoperative pain (P<0.001), consumed fewer analgesics (P<0.001), had a shorter period of sick leave (7 versus 12 days; P<0.001) and a shorter time to resumption of normal physical activity (20 versus 31 days; P<0.001). CONCLUSION: The TEP technique took no longer to perform, and was associated with less postoperative pain, a shorter period of sick leave and a faster recovery, compared with open Lichtenstein hernia repair.

Graves' disease with moderate-severe endocrine ophthalmopathy-long term results of a prospective, randomized study of total or subtotal thyroid resection.

The optimal thyroid surgery to be performed in patients with Graves' disease and concomitant endocrine ophthalmopathy is a matter of debate. We randomly assigned 44 patients with moderate-severe eye signs in a trial of treatment with subtotal, leaving a small (approximately 2 g) thyroid remnant, or total thyroidectomy. At inclusion, the patients had been treated with antithyroid drugs, and corticosteroids been given to 12 (27%). All received postoperative thyroxine supplementation and were followed for 3 years at regular examinations. The eye disease improved in all cases, and throughout the study, the two groups did not differ with regard to subjective and objective eye symptoms and laboratory findings. At the study start, motility disturbances were present in 8 and 11 of the cases in the subtotal and total resection group and proptosis in 16 and 17, respectively. After 3 years, the corresponding data were 3 and 6 cases with motility defects and 16 and 15 cases with proptosis. Thyrotropin (TSH)-receptor antibody levels gradually fell and became nondetectable in 21 (49%). The surgical complication rate (permanent recurrent laryngeal nerve paresis and permanent hypoparathyroidism) was significantly higher in the total thyroidectomy group. The data indicate that in patients with Graves' disease and active endocrine ophthalmopathy, subtotal thyroidectomy, leaving a small thyroid remnant, will reduce the risk of surgical complications but not the beneficial effect of surgery.

Randomized clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia.

BACKGROUND: The Shouldice technique is the 'gold standard' of open non-mesh hernia repair. The aim of this study was to compare 5-year recurrence rates after Shouldice and laparoscopic transabdominal preperitoneal patch (TAPP) repair for primary inguinal hernia. METHOD: Men with a primary unilateral inguinal hernia were randomized to either Shouldice or TAPP operation. An independent observer scored the surgeons' performance. Follow-up comprised clinical examination after 1 year, a questionnaire after 2 and 3 years, and a clinical examination after 5 years. RESULTS: Between February 1993 and March 1996, 1183 patients were included. Nine hundred and twenty patients were followed for 5 years, 454 in the TAPP group and 466 in the Shouldice group. Recurrences were evenly distributed between groups throughout the follow-up period. The cumulative recurrence rate after 5 years was 6.6 per cent in the TAPP group and 6.7 per cent in the Shouldice group. Postoperative pain was a risk factor for recurrence after Shouldice operation but not after TAPP repair. There was a correlation between a low surgeon's performance score and recurrence. CONCLUSION: The 5-year recurrence rate is acceptable, with no difference between TAPP and Shouldice repair. Poor operative performance resulted in a higher recurrence rate. The TAPP operation represents an excellent alternative for primary inguinal hernia repair.

The Fenyö-Lindberg scoring system for appendicitis increases positive predictive value in fertile women--a prospective study in 455 patients randomized to either laparoscopic or open appendectomy.

BACKGROUND: Suspected appendicitis is one of the most common indications for acute laparotomy or laparoscopy. The negative laparotomy and laparoscopy rates are high, often in the range of 15-30%, and especially high in some groups of patients such as women of child-bearing age and young patients. Different scoring systems have been introduced in order to improve diagnostic accuracy. The aim of the present study was to analyse the outcome of the Fenyö-Lindberg scoring system in a prospectively randomized multicenter trial and to analyze how well the score performed in stratified subgroups. METHODS: The variables of the Fenyö-Lindberg scoring system were collected in a prospective study comparing laparoscopic and open surgery in suspected appendicitis and with four participating centers. None of the hospitals had used the scoring system previously. Since surgeons were unfamiliar with the score, they could not use it as a diagnostic aid. When comparing the score with the clinical outcome, retrospectively, the investigators interpreting the score were blinded regarding the surgical outcome. RESULTS: Positive predictive value (PPV) of the Fenyö-Lindberg score was higher than that of the surgeon's clinical diagnosis in the patient cohort [0.90 vs 0.79 (p < 0.001)]. The score demonstrated an improvement of PPV in women [0.83 vs 0.70 (p < 0.01)]. PPV was increased in women between 15 and 50 years of age. In women aged 15-30 years and 31-50 years PPV increased from 0.69 to 0.82 and 0.68 to 0.86, respectively (p < 0.01). Both the sensitivity (0.77) and the specificity (0.69) of the score were, however, low. CONCLUSION: The Fenyö-Lindberg score is an inexpensive clinical tool that may improve the diagnostic accuracy for acute appendicitis in women of childbearing age, which is a group of patients where the diagnostic accuracy usually is low and where the arsenal of diagnostic tools such as computed tomography is limited because of radiation. The low specificity of the score in women of childbearing age must, however, be kept in mind.

Postoperative convalescence after inguinal hernia surgery: prospective randomized multicenter study of laparoscopic versus shouldice inguinal hernia repair in 1042 patients.

Interest in inguinal hernia surgery has increased significantly with the introduction of new operating techniques during the past decade. This multicenter study compared short-term results in patients treated by the laparoscopic transabdominal preperitoneal patch technique (TAPP; n = 518) and the Shouldice technique (n = 524). We evaluated demographics, operative data, complications, hospital stay, postoperative pain, use of cs, functional status, sick leave, and complaints up to 3 months postoperatively. The median operating time was shorter in the Shouldice group (55 vs. 65 min), but there were no significant differences in complication rates, and major complications were rare. The hospital stay was 1 day or less in over 98% of cases in both groups, but more operations were performed on outpatient basis in the Shouldice group. In the TAPP group postoperative pain and analgesic consumption were less, postoperative functional status was better, and sick leave was shorter (10 vs. 14 days). These results show that the two methods are equally safe and have few major complications. The TAPP operation is associated with less postoperative pain, better postoperative functional status, and shorter sick leave, but at the price of a longer operating time.

Laparoscopic vs open appendectomy in overweight patients.

BACKGROUND: Laparoscopic appendectomy (LA) has been associated with a faster recovery and less postoperative pain than the open technique. However, few data are available on the clinical outcome of LA in overweight patients. METHODS: A group of 106 patients with a body mass index (BMI) > 26.4, representing the upper quintile of 500 prospectively randomized patients, were included in the study. They were randomized to undergo either laparoscopic or open appendectomy (OA). Operating and anesthesia times, postoperative pain, complications, hospital stay, functional index (1 week postoperatively), sick leave, and time to full recovery were documented. RESULTS: In OA, the operating time for overweight patients was significantly longer than that for patients in the normal weight range (40 vs 35 min, p < 0.05). In LA, there was no difference in operating time between the normal and overweight patients. Overweight patients who underwent LA had longer operating and anesthesia times than their OA counterparts (55 vs 40 min, p < 0.001; and 125 vs 100 min, p < 0.001, respectively). Postoperative pain was significantly greater in overweight patients who underwent OA than in those treated with the laparoscopic technique. Postoperative pain was also significantly greater in overweight patients subjected to OA than in patients of normal weight after 4 weeks; the clinical significance may, however, be of less importance since the values are low (0.26 vs 0.09, p < 0.05). There were no significant differences between the two operating techniques in terms of complications. Hospital stay was longer for overweight patients than for normal-weight patients undergoing OA (3.0 vs 2.0, p < 0.01). The functional index did not differ between any group of patients. Sick leave was longer for overweight patients who underwent OA than for normal-weight patients treated with the same technique (17 vs 13 days, p < 0.01). In the laparoscopic group, however, there were no differences between the overweight and normal-weight patients. Time to full recovery was greater in overweight patients subjected to OA than in the overweight patients in the LA group (22 vs 15 days, p < 0.001). CONCLUSION: In this study, overweight patients who were submitted to LA had less postoperative pain and a faster postoperative recovery than overweight patients who had OA. LA also abolished some of the negative effects that overweight had on operating time, hospital stay, and sick leave with the open technique. However, anesthesia and operating times were significantly longer in LA for both overweight patients and those with a normal BMI.

Conversion from laparoscopic to open appendicectomy: a possible drawback of the laparoscopic technique?

OBJECTIVE: To analyse the reasons for, and outcome of, conversion from laparoscopic to open appendicectomy and to identify factors that may predict the need for conversion. DESIGN: Subgroup analysis from a randomised multicentre study. SETTING: One university hospital and four county hospitals, Sweden. SUBJECTS: A total of 500 patients were randomised to laparoscopic (n = 244) or open (n = 256) appendicectomy. Thirty operations (12%) were converted to open appendicectomy. MAIN OUTCOME MEASURES: Reasons for conversion, outcome, and preoperative predictive variables. RESULTS: Difficult anatomy or the presence of an abscess were the main reasons for conversion (25/30). The incidence of perforated appendicitis was higher among patients who required conversion compared with both the open and laparoscopic group. Operating time, anaesthetic time, and duration of hospital stay were longer after conversion. Time to full recovery and length of sick leave were also longer, except for patients with perforated appendicitis. There was no difference in the complication rate. No predictive factors were identified. CONCLUSION: The main reasons for conversion were difficult anatomy and the presence of an abscess. After conversion patients recovered more slowly than those operated on laparoscopically or by primary open operation.

[Laparoscopic surgery--evidence-based ?]. / Laparoskopisk kirurgi--hur evidensbaserad är den?

The literature has been searched for current results in laparoscopic cholecystectomy, hernia repair, appendectomy and fundoplication. This was performed as a systematic review. Laparoscopic cholecystectomy was judged to be safe and cost/effective, with good patient acceptability. However a need for further studies is indicated. Laparoscopic technique in hernia repair has a longer learning curve and is more expensive than open repair, with no major difference in recurrence rates. It is preferable in bilateral repairs. Laparoscopic appendectomy in the hands of experienced surgeons is cost/effective. Time to recovery is shorter and the rate of infectious complications is lower than in conventional procedures. There are still too few results reported from laparoscopic fundoplication to permit reliable conclusions.

Cost-minimisation analysis of laparoscopic and open appendicectomy.

OBJECTIVE: To compare the direct and indirect costs of laparoscopic and open appendicectomy. DESIGN: Randomised study. SETTING: University hospital, Sweden. MAIN OUTCOME MEASURES: Total costs for a defined period of time for each option. RESULTS: 102 patients were randomised and 99 were included in the final analysis. All patients had completely recovered within two months of operation. Disposable extra material used for the laparoscopic operation and longer operating time raised its median cost by SEK 912 and 1785, respectively. The mean duration of hospital stay, period off work (indirect costs), and time to complete recovery did not differ between the groups. CONCLUSION: Laparoscopic appendicectomy has higher direct costs than open operation and is not as cost-effective when the longterm outcome is the same in both groups.

Prospective randomized multicentre study of laparoscopic versus open appendicectomy.

BACKGROUND: A prospective randomized multicentre study was performed to compare the outcome of laparoscopic and open appendicectomy in patients with suspected acute appendicitis. METHODS: A total of 523 patients was randomized, but because of 23 withdrawals the outcome in 500 patients is reported, 244 in the laparoscopic group and 256 in the open group. RESULTS: Patients having laparoscopic appendicectomy recovered more quickly than those having open surgery (13 versus 21 days, P < 0.001). There was no significant difference in duration of sick leave after operation (laparoscopic group 11 days versus open group 14 days). Postoperative pain (at 24 h, 7 days and 14 days) was less after laparoscopic operations and a functional index 1 week after operation was more favourable in these patients (P < 0.001). Operating time was significantly longer in the laparoscopic group (60 versus 35 min, P < 0.01). Hospital stay and complications did not differ between the groups. Thirty laparoscopic procedures (12 per cent) were converted to open appendicectomy. CONCLUSION: Laparoscopic appendicectomy is as safe as open appendicectomy and has the advantage of allowing a quicker recovery.

Graves' disease in children and adolescents. Late results of surgical treatment.

All children and adolescents with Graves' disease in the county of Uppsala (catchment area population 250,000) treated between 1970 and 1994 were evaluated in a retrospective study. The material comprised 31 patients with a mean age of 11 years (range 4-16), 29 (94%) of whom were girls, and four (13%) of the patients had Down's syndrome. Treatment was primarily conservative and surgery was considered if prolonged medical treatment failed. Lasting remission after antithyroid drug therapy (median 6.5 years; range 4.5-8 years) was noted in 6/31 patients (19%), three (10%) of whom subsequently developed hypothyroidism. Twenty-four of the remaining patients (77%) ultimately underwent subtotal (N = 20) or total thyroidectomy (N = 4) after experiencing one or more episodes of recurrent hyperthyroidism during medical treatment (median 6 years; range 0.5-11 years). After surgery one patient developed permanent hypocalcemia requiring low-dose vitamin D supplementation. During a postoperative follow-up period of 12.2 years ( median; range 1-17 years), there were two cases of recurrent thyrotoxicosis, 1 and 10 years after surgery. The results underline that gender and Down's syndrome are risk factors of juvenile Graves' disease and that the disorder often is difficult to control by long-term medical therapy. In such cases thyroid surgery offers a safe and prompt reversal of the thyrotoxicosis. A proportion of the patients may ultimately develop hypothyroidism, substantiating a need for long-term follow-up of persons afflicted with Graves' disease early in life.

Incidence, structure, and function of enlarged parathyroid glands discovered accidentally during thyroid surgery.

BACKGROUND: Operation on rare patients with mainly a severe renal stone disease and considerably elevated urinary calcium excretion has substantiated the association of parathyroid gland abnormalities with normocalcemia. This study examines incidence, structure, and functional characteristics of enlarged parathyroid glands of patients with normocalcemia scheduled for thyroid surgery. METHODS: Eleven enlarged parathyroid glands weighing 110 to 1000 mg were discovered in 9 (1.5%) of 594 patients with normocalcemia undergoing thyroid operation. The preoperative total serum calcium concentration was 2.30 to 2.52 mmol/L and less than 2.38 mmol/L in four of the nine patients. Intact serum parathyroid hormone and alkaline phosphatase levels were elevated in only one individual, and all patients showed normal serum creatinine values. RESULTS: All but three of the 11 enlarged parathyroid glands exhibited microscopic abnormality on routine histopathologic examination, including staining for cytoplasmic fat with oil red 0. Immunohistochemical staining with a monoclonal antibody recognizing the functionally important calcium receptor of the parathyroid cell surface and analysis of the calcium-regulated cytoplasmic Ca2+ concentration of dispersed parathyroid cells substantiated that only a single gland of 130 mg had no discernible functional abnormality. CONCLUSIONS: The findings underline the diagnostic difficulties of parathyroid histopathology and support the presence of disturbed parathyroid hormone secretion even in normocalcemic patients with enlarged parathyroid glands. The functional derangement of these glands substantiates the indication for their surgical excision even in patients exhibiting midnormal serum calcium concentrations, although their possible contribution to the development of a clinically overt hyperparathyroidism can only be speculated.

Causes of failed primary exploration and technical aspects of re-operation in primary hyperparathyroidism.

Hypercalcemia was corrected in 62 (90%) of 69 patients after re-operation for primary hyperparathyroidism during a mean follow-up of 6.3 years. Failed primary exploration was mainly due to inadequate visualization of the pathological parathyroid glands, often in association with misleading or absent peroperative histology. Other causes included seeding of parathyroid adenoma tissue, truly recurrent adenomas, and recurrent hyperplasia, especially in patients with multiple endocrine neoplasia type 1. A considerable number of parathyroid glands missed at the primary operations were subsequently found in essentially normal positions. Ectopic superior glands were most frequently positioned para-esophageally or retro-esophageally, while abnormally placed inferior glands were generally situated within or close to the thymus. Glands in 3 patients were dissected from around the large vessels in the mediastinum. Concomitant thyroid procedures during the primary operation yielded few abnormal parathyroids and made the re-exploration considerably more difficult. We suggest a semilateral approach and caudal identification of the recurrent laryngeal nerve to reduce the hazards of difficult parathyroid re-operations. Mediastinal exploration may require total removal of the thymus and careful dissection of the middle mediastinum.

Histological and clinical features of non-familial primary parathyroid hyperplasia.

Relations between histopathological characteristics and clinical data were retrospectively investigated in patients with sporadic primary hyperparathyroidism due to hyperplasia. The study comprised 100 patients with chief cell hyperplasia and nine with hyperplasia of the water-clear cell type operated on during the period of 1959-1989. The chief cell hyperplasia was associated with a renal stone disorder as the predominant symptom in 41 patients, psychiatric/neuromuscular manifestations in 26 patients, while 23 patients were apparently asymptomatic. The remaining ten patients had miscellaneous symptoms. Patients with renal stones were more frequently of the male sex and generally had lower serum calcium values and less marked increments in total parathyroid glandular weights than patients with other symptoms or those who were overtly asymptomatic. Two main morphological patterns, diffuse and nodular hyperplasia, were encountered in chief cell hyperplasia. Diffuse hyperplasia was usually found in moderately enlarged glands, with a less variable size and morphology. It was also more prevalent among young patients having moderate hypercalcaemia and either recurrent renal stones or neuromuscular/psychiatric symptoms. The glands affected by nodular hyperplasia were asymmetric in size with a variable cellular arrangement and a high proportion of oxyphil cells. Nodular hyperplasia was irrespective of symptoms more frequent in the elderly patients. Water-clear cell hyperplasia was not encountered during the last decade of the study and until then it was an occasional finding in patients with marked hypercalcaemia. In this histological entity the glands were greatly and asymmetrically enlarged.

Volvulus of the colon. A review of 93 cases and current aspects of treatment.

Ninety-three patients, comprising a consecutive, population-based series, were treated for volvulus of the colon between 1970 and 1985. The male:female ratio was 3.3:1 among the patients with volvulus of the sigmoid colon and 1:3.7 among those with caecal volvulus (p less than 0.001). Of the 60 patients with sigmoid volvulus, nine (15%) died. Elective surgery was performed in 13 of these 60 cases, without postoperative mortality. Previous volvulus attack(s) had occurred in 22 of the 60. Of the nine patients who underwent only detorsion at laparotomy, four had recurrence. Of the 33 patients with caecal volvulus, 31 underwent emergency laparotomy, and in seven of them the outcome was fatal. Of the nine patients who survived pexis operations, three had recurrence of volvulus. The results indicate that immediate laparotomy can be hazardous in patients with colonic volvulus. Semi-emergency resection after tube decompression, when the patient is in optimal condition and with preoperatively prepared bowel, is probably preferable.